(193 days)
Not Found
No
The summary describes a spinal implant system and associated instruments, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The focus is on the physical components and their intended use for spinal stabilization and fusion.
Yes
Explanation: The device is intended to correct spinal disorders, provide stabilization for spinal fusion, and treat various acute and chronic instabilities or deformities of the spine. These functions directly address health conditions and aim to restore or improve physiological function, which aligns with the definition of a therapeutic device.
No
The device description indicates that the Malibu system consists of surgical implants (screws, connectors, rods, crossbars) and instruments (screw drivers, bone probes) used for spinal stabilization and fusion. These are treatment devices, not diagnostic devices which are used to identify or detect medical conditions.
No
The device description explicitly details physical components made of titanium alloy, cobalt alloy, stainless steel, Radel, and silicone, which are hardware implants and instruments. There is no mention of software as a component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Malibu system is a spinal implant and associated instruments used for surgical procedures to stabilize the spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to correct spinal disorders and provide stabilization for fusion, which is a surgical intervention, not a diagnostic test.
Therefore, the Malibu system falls under the category of a surgical implant/device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Malibu system is as a temporary or permanent posterior, noncervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. ●
- . trauma (i.e., fracture or dislocation),
- spinal stenosis.
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- . spinal tumor.
- . pseudoarthrosis, and/or
- failed previous fusion. .
The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation),
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
- . tumor,
- pseudarthosis, and/or .
- . failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, KWP
Device Description
The Malibu system will include cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, and countoured crossbars. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component. All products are being offered in a wide variety of different sizes. The Malibu parts in this submission are being added to the current Malibu product line, but these items are also compatible with and work in conjunction with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also offer a wide variety of instruments that range from polyaxial screw drivers to bone probes. These instruments will be made from various grades of stainless steel with a few handles made from Radel and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to sacrum, T1-L5
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All products passed testing per applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031175, K002607, K992168, K993503, K021623, K031381, K032739/S1, K043232, K051663, K051942
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
OCT 2 5 2006
K06/342
CONFIDENTIAL
510(K) SUMMARY
Malibu™M
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Diana Smith
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.
Contact: Diana Smith, Manager of
Regulatory Affairs and Quality Assurance
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
| Date Summary Prepared: | April 4, 2006 |
| Classification Name: | Pedicle Screw Spinal System
MNH (Class II) - 888.3070(b)(1)
MNI (Class II) - 888.3070(b)(1)
NKB (Class III) - 888.3070(b)(2)
Spinal Interlaminal Fixation Orthosis
KWP (Class II) - 888.3050 |
| Common/Usual Name: | Cannulated polyaxial screws, closed lateral
connectors, rod connectors, precontoured
rods, contoured crossbars, components, and
instruments |
| Device Trade Name: | Malibu™ |
The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monoaxial Screw System (K031175), DePuy Acromed's Moss Miami System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232) and Malibu Spinal System (K051663 and K051942).
- Intended Use: (The statements of intended use are identical.)
The intended use of the Malibu system is as a temporary or permanent posterior, noncervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
1
The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. ●
- . trauma (i.e., fracture or dislocation),
- spinal stenosis.
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- . spinal tumor.
- . pseudoarthrosis, and/or
- failed previous fusion. .
The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), �
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
- . tumor,
- pseudarthosis, and/or .
- . failed previous fusion.
2. Description:
The Malibu system will include cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, and countoured crossbars. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component. All products are being offered in a wide variety of different sizes. The Malibu parts in this submission are being added to the current Malibu product line, but these items are also compatible with and work in conjunction
2
with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also offer a wide variety of instruments that range from polyaxial screw drivers to bone probes. These instruments will be made from various grades of stainless steel with a few handles made from Radel and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, components, and instruments in this notification are components being added to the previously cleared Malibu system, but are designed to be compatible with and work in conjunction with the components in the current SeaSpine UCR system. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
4. Comparison Analysis:
The overall designs of the cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, contoured crossbars, and components to the predicate devices.
3
Malibu™
| Feature | Malibu Spinal System | Synthes
Click'X
Monoaxial
System | Moss Miami
Spinal System | SeaSpine UCR
and Malibu
Spinal Systems | Substantially
Equivalent |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|----------------------------------------------|-----------------------------|
| Intended Use | The intended use of the
Malibu system is as a
temporary or permanent
posterior, non-cervical
implant to correct spinal
disorders and provide
stabilization of the spine to
permit the biological
process of spinal fusions to
occur. | Similar | Similar | Similar | Yes |
| Indications for
Use | Degenerative disc disease
(DDD) as defined by back
pain of discogenic origin
with degeneration of the
disc confirmed by patient
history and radiographic
studies,
• spondylolisthesis,
• trauma (i.e., fracture or
dislocation),
• spinal stenosis,
• deformities or curvatures
(i.e., scoliosis, kyphosis,
and/or lordosis),
• tumor,
• pseudarthosis, and/or
• failed previous fusion. | Similar | Similar | Similar | Yes |
| Design | Cannulated polyaxial screws,
closed lateral connectors, rod
connectors, precontoured
rods, contoured crossbars,
and components. | Similar | Similar | Similar | Yes |
| Cannulated
Polyaxial
Screws | Various sizes | Similar | Similar | Similar | Yes |
| Closed Lateral
Connectors | Various sizes | Similar | Similar | NA | Yes |
| Rod
Connectors | Various sizes | Similar | Similar | NA | Yes |
| Precontoured
Rods | Various sizes | Similar | Similar | Similar | Yes |
| Contoured
Crossbars | Various sizes | Similar | Similar | Similar | Yes |
| Material | Titanium alloy, cobalt alloy | Similar | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Similar | Similar | Yes |
| Method of
Sterilization | High-temperature steam | Similar | Similar | Similar | Yes |
| Mechanical
Strength | All products passed testing
per applicable standards. | Similar | Similar | Similar | Yes |
Table 1: Summary of Design Comparison
:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is rendered in a bold, black color, while the text is also in black but with a thinner font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. % Ms. Ethel Bernal Document Control Specialist 2302 La Miranda Drive Vista, California 92081
OCT 2 5 2006
Re: K061342
Trade/Device Name: Malibu Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Fixation System Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: September 5, 2006 Received: October 10, 2006
Dear Ms. Bernal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Ethel Bernal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chabane Buchm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
Device Name: Malibu
Indications for Use:
The intended use of the Malibu spinal system is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. .
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis, .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
AND/OR
- . spinal tumor,
- pseudoarthrosis, and/or .
- failed previous fusion. .
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
| (Division Sign-Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| Division of General, Restorative, | Indications for Use Statement continued |
and Neurological Devices
510(k) Number
7
The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- tumor, .
- pseudarthosis, and/or .
- failed previous fusion. .
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
| Barbara Buchun | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K011342 |